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Clinical Trial
. 2024 Sep;168(3):781-791.
doi: 10.1016/j.jtcvs.2023.09.047. Epub 2023 Sep 29.

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis

Thomas Beaver  1 , Joseph E Bavaria  2 , Bartley Griffith  3 , Lars G Svensson  4 , Philippe Pibarot  5 , Michael A Borger  6 , Omar M Sharaf  7 , David A Heimansohn  8 , Vinod H Thourani  9 , Eugene H Blackstone  4 , John D Puskas  10 ; COMMENCE Trial Investigators
Affiliations
Free article
Clinical Trial

Seven-year outcomes following aortic valve replacement with a novel tissue bioprosthesis

Thomas Beaver et al. J Thorac Cardiovasc Surg. 2024 Sep.
Free article

Abstract

Objective: As bioprosthetic aortic valve replacement (AVR) extends to younger cohorts, tissue durability is of paramount importance. We report 7-year outcomes from an AVR bioprosthesis utilizing novel tissue.

Methods: This was an international investigational device exemption trial for novel AVR with annual follow-up and a subset re-consented at 5 years for extended 10-year follow-up. Safety end points and echocardiographic measurements were adjudicated by an independent clinical events committee and by a dedicated core laboratory, respectively.

Results: Between January 2013 and March 2016, 689 patients underwent AVR with the study valve. Mean age was 66.9 ± 11.6 years, Society of Thoracic Surgeons risk score was 2.0% ± 1.8%, and 74.3% of patients were New York Heart Association functional class II and III. Five-year follow-up was completed by 512 patients, and 225 re-consented for extended follow-up. Follow-up duration was 5.3 ± 2.2 years (3665.6 patient-years), and 194 and 195 patients completed 6- and 7-year follow-ups, respectively. One-, 5-, and 7-year freedom from all-cause mortality was 97.7%, 89.4%, and 85.4%, respectively. Freedom from structural valve deterioration at 7 years was 99.3%. At 7 years, effective orifice area and mean gradients were 1.82 ± 0.57 cm2 (n = 153), and 9.4 ± 4.5 mm Hg (n = 157), respectively. At 7 years, predominantly none (96.8% [152 out of 157]) or trivial/trace (2.5% [4 out of 157]) paravalvular regurgitation and none (84.7% [133 out of 157]) or trivial/trace (11.5% [18 out of 157]) transvalvular regurgitation were observed.

Conclusions: We report the longest surgical AVR follow-up with novel tissue in an investigational device exemption trial utilizing an independent clinical events committee and an echocardiography core laboratory. This tissue demonstrates excellent outcomes through 7 years and is the benchmark for future surgical and transcatheter prostheses.

Keywords: RESILIA tissue; aortic valve disease; aortic valve replacement; bioprosthetic valve.

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Conflict of interest statement

Conflict of Interest Statement Dr Beaver is on the Data Safety Monitoring Board at Nexxus, a study site investigator and consultant for Edwards Lifesciences, and a study site principal investigator and consultant for Atricure. Dr Thourani is an advisor/research for Edwards Lifesciences. Dr Pibarot has received institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, and Cardiac Success for echocardiography core laboratory analyses and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. All other authors reported no conflicts of interest. The Journal policy requires editors and reviewers to disclose conflicts of interest and to decline handling manuscripts for which they may have a conflict of interest. The editors and reviewers of this article have no conflicts of interest.

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